SUPPLY CHAIN ARTICLES

• FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

  The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

• Therapeutic Oligonucleotides: Regulations & Quality Standards

  Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.

• The mRNA Supply Chain Revolution: Materials, Methods, And Momentum

  mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.

• Addressing Challenges In Serialization For Complex Therapeutics

  The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.

• mRNA Vaccines: Key Considerations For Development & Manufacturing

  As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more. 

• The Price Is… Almost Right: mRNA Edition! COGS Reduction Strategies

  The following article will outline the current state of COGS in the mRNA industry and the work he and his colleagues undertook to more effectively utilize raw materials. But heaven forbid this be your normal conference panel write-up. No, below I share Parrella’s insights, but in the form of a never-before released episode of The Price is Right…or perhaps more fittingly given the state of the industry today, this spectacle is more aptly titled: The Price is…Sort Of, Almost, Not Quite Right!